An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)

NCT01609075 | Completed

• 1 other identifier: ML27907
• Study Type: observational
• Target: 437
• Locations: 1 country
• Sites: 72

Brief Summary

This observational, multicenter, retrospective/prospective study will evaluate the use of Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer. Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and Avastin will be followed for up to 15 months.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events

  approximately 15 months

Secondary Outcomes (4)

• Proportion of patients with treatment discontinuation due to other causes

  approximately 15 months

• Incidence of other causes for treatment discontinuation

  approximately 15 months

• Second-line treatments initiated

  approximately 15 months

• Progression-free survival (patients with treatment discontinuation due to disease progression or Avastin-related toxicity as compared to patients with treatment discontinuation due to other causes)

  approximately 15 months

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin

You may qualify if:

• Adult patients, \>/= 18 years of age
• Metastatic colorectal cancer
• Having initiated first-line treatment with fluoropyrimidine-based chemotherapy plus Avastin between 1. September 2011 and 29. February 2012
• Availability of test fro K-RAS genotyping

You may not qualify if:

• Participation in a clinical trial during treatment with Avastin

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (72)

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L’Aquila, Abruzzo, 67010, Italy

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Teramo, Abruzzo, 64100, Italy

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Brindisi, Apulia, 72100, Italy

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Castellana Grotte (BA), Apulia, 70013, Italy

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Foggia, Apulia, 71100, Italy

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Lecce, Apulia, 73100, Italy

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San Giovanni Rotondo, Apulia, 71013, Italy

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Rionero in Vulture, Basilicate, 85028, Italy

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Cosenza, Calabria, 87100, Italy

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Lamezia Terme (CZ), Calabria, 88046, Italy

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Reggio Calabria, Calabria, 89100, Italy

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Benevento, Campania, 82100, Italy

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Napoli, Campania, 80100, Italy

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Napoli, Campania, 80131, Italy

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Pagani ( Sa), Campania, 84016, Italy

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Imola (BO), Emilia-Romagna, 40026, Italy

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Modena, Emilia-Romagna, 41100, Italy

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Parma, Emilia-Romagna, 43100, Italy

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Pordenone, Friuli Venezia Giulia, 33170, Italy

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Albano Laziale, Lazio, 00041, Italy

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Rome, Lazio, 00128, Italy

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Rome, Lazio, 00157, Italy

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Rome, Lazio, 00185, Italy

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Rome, Lazio, 00189, Italy

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Sora, Lazio, 03039, Italy

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Viterbo, Lazio, 01100, Italy

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Genoa, Liguria, 16132, Italy

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La Spezia, Liguria, 19100, Italy

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Savona, Liguria, Italy

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Bergamo, Lombardy, 24121, Italy

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Brescia, Lombardy, 25124, Italy

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Cremona, Lombardy, 26100, Italy

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Lecco, Lombardy, 23900, Italy

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Milan, Lombardy, 20099, Italy

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Milan, Lombardy, 20142, Italy

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Monza, Lombardy, 20900, Italy

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Pavia, Lombardy, 27100, Italy

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S. Fermo Della Battaglia (CO), Lombardy, 22020, Italy

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Saronno, Lombardy, 21047, Italy

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Varese, Lombardy, 21100, Italy

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Cuneo, Piedmont, 12100, Italy

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Novara, Piedmont, 28100, Italy

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Orbassano, Piedmont, 10043, Italy

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Ponderano (BI), Piedmont, 13875, Italy

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Turin, Piedmont, 10126, Italy

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Turin, Piedmont, 10153, Italy

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Cagliari, Sardinia, 09121, Italy

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Sassari, Sardinia, 07100, Italy

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Catania, Sicily, 95123, Italy

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Cefalù, Sicily, 90015, Italy

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Messina, Sicily, 98125, Italy

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Messina, Sicily, 98158, Italy

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Palermo, Sicily, 90100, Italy

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Taormina, Sicily, 98030, Italy

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Vimercate, Sicily, 20059, Italy

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Fano, The Marches, 61032, Italy

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Fermo, The Marches, 63023, Italy

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Macerata, The Marches, 62100, Italy

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Grosseto, Tuscany, 58100, Italy

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Lido di Camaiore, Tuscany, 55043, Italy

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Livorno, Tuscany, 57100, Italy

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Pontedera, Tuscany, 56025, Italy

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Siena, Tuscany, 53100, Italy

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Perugia, Umbria, 06156, Italy

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Cona (Ferrara), Veneto, 44124, Italy

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Este, Veneto, 35042, Italy

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Este (PD), Veneto, 35042, Italy

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Mirano, Veneto, 30035, Italy

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Montecchio Maggiore, Veneto, 36075, Italy

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Padua, Veneto, 35128, Italy

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Rovigo, Veneto, 45100, Italy

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Treviso, Veneto, 31100, Italy

Location

Related Publications (1)

• Lonardi S, Nasti G, Fagnani D, Gemma D, Ciuffreda L, Granetto C, Lucchesi S, Ballestrero A, Biglietto M, Proserpio I, Bergamo F, Proietti E, Tonini G. Discontinuation of first-line bevacizumab in metastatic colorectal cancer: the BEAWARE Italian Observational Study. Tumori. 2019 Jun;105(3):243-252. doi: 10.1177/0300891619834126. Epub 2019 Mar 11.

  PMID: 30857495 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

IT (72)